Bioequivalence Study of Fixed Dose Versus Single Entities of Dolutegravir and Lamivudine

PHASE1CompletedINTERVENTIONAL
Enrollment

154

Participants

Timeline

Start Date

March 27, 2017

Primary Completion Date

August 18, 2017

Study Completion Date

August 18, 2017

Conditions
Infection, Human Immunodeficiency Virus
Interventions
DRUG

Dolutegravir

Single dose of DTG 50 mg tablet along with 3TC (EPIVIR) tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water. DTG will be a white, film coated, round tablet engraved with SV 572 on one side and 50 on the other side.

DRUG

Lamivudine

"Single dose 3TC (commercial name: EPIVIR) 300 mg tablet along with DTG tablet will be given to randomized subjects in parts 1 and 2 with 240 mL of room temperature water.\<br\>3TC will be gray, diamond shaped tablet, engraved GX EJ7 on one side and plain on the other side."

DRUG

Dolutegravir + Lamivudine FDC Formulation 1

Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 1 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) of Part 1 and the first 16 subjects in treatment period 3 (under fed) of Part 1 with 240 mL of room temperature water. \&lt;br\&gt;FDC formulation 1 tablets will be oval, biconvex, white, film coated tablet engraved 'SV H7I' on one face.

DRUG

Dolutegravir + Lamivudine FDC Formulation 2

Single dose of DTG 50 mg combined with 3TC 300 mg in a FDC formulation 2 tablet will be administered to randomized subjects in treatment periods 1 and 2 (under fasted state) and the first 16 subjects in treatment period 3 (under fed) of Part 2 with 240 mL of room temperature water. \&lt;br\&gt;FDC formulation 2 tablets will be oval, biconvex, white, film coated tablet engraved 'SV 13N' on one face.

Trial Locations (1)

66211

GSK Investigational Site, Overland Park

Sponsors

Lead Sponsor

Collaborators (1)

All Listed Sponsors
collaborator

GlaxoSmithKline

INDUSTRY

lead

ViiV Healthcare

INDUSTRY